Cleared Traditional

K091579 - FORESEE HOME

K091579 is an FDA 510(k) clearance for FORESEE HOME, manufactured by Notal Vision , Ltd.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K091579 · Notal Vision , Ltd. · Ophthalmic device
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Dec 2009
Decision
204d
Days
Class 1
Risk

K091579 is an FDA 510(k) clearance for the FORESEE HOME. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Notal Vision , Ltd. (Laguna Beach, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Notal Vision , Ltd. devices

FDA 510(k) Submission Details - K091579

510(k) Number K091579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date December 23, 2009
Days to Decision 204 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

All 9
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K091579.
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